[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.401]



[Page 452-453]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

       Subpart E_Corrective Actions and Cessation of Dissemination

 

Sec.  99.401  Corrective actions and cessation of dissemination of 

information.





    (a) FDA actions based on post dissemination data. If FDA receives 

data after a manufacturer has begun disseminating information on a new 

use and, based on that data, determines that the new use that is the 

subject of information disseminated under this part may not be effective 

or may present a significant risk to public health, FDA shall consult 

the manufacturer and, after such consultation, take appropriate action 

to protect the public health. Such action may include ordering the 

manufacturer to cease disseminating information on the new use and to 

take appropriate corrective action.

    (b) FDA actions based on information disseminated by a manufacturer. 

If FDA determines that a manufacturer is disseminating information that 

does not comply with the requirements under this part, FDA may:

    (1) Provide to the manufacturer an opportunity to bring itself into 

compliance with the requirements under this part if the manufacturer's 

noncompliance constitutes a minor violation of these requirements; or

    (2) Order the manufacturer to cease dissemination of information and 

to take corrective action. FDA shall issue such an order only after it 

has:

    (i) Provided notice to the manufacturer regarding FDA's intent to 

issue an order to cease dissemination; and

    (ii) Provided to the manufacturer an opportunity for a meeting. FDA 

need not provide an opportunity for a meeting if the manufacturer 

certified that it will submit a supplemental application for the new use 

within 6 months of the date that dissemination can begin and the 

noncompliance involves a failure to submit such supplemental 

application.

    (c) FDA actions based on a manufacturer's supplemental application. 

FDA may



[[Page 453]]



order a manufacturer to cease disseminating information under this part 

and to take corrective action if:

    (1) In the case of a manufacturer that has submitted a supplemental 

application for the new use, FDA determines that the supplemental 

application does not contain adequate information for approval of the 

new use;

    (2) In the case of a manufacturer that has certified that it will 

submit a supplemental application for the new use within 6 months, the 

manufacturer has not, within the 6-month period, submitted a 

supplemental application for the new use;

    (3) In the case of a manufacturer that has certified that it will 

submit a supplemental application for the new use within 36 months or 

within such time as FDA has determined to be appropriate under Sec.  

99.303(a) or (b), such manufacturer has not submitted the supplemental 

application within the certified time, or FDA, after an informal 

hearing, has determined that the manufacturer is not acting with due 

diligence to initiate or complete the studies necessary to support a 

supplemental application for the new use; or

    (4) In the case of a manufacturer that has certified that it will 

submit a supplemental application for the new use within 36 months or 

within such time as FDA has determined to be appropriate under Sec.  

99.303(a) or (b), the manufacturer has discontinued or terminated the 

clinical studies that would be necessary to support a supplemental 

application for a new use.

    (d) Effective date of orders to cease dissemination. An order to 

cease dissemination of information shall be effective upon date of 

receipt by the manufacturer, unless otherwise stated in such order.

    (e) Cessation of dissemination by a noncomplying manufacturer. A 

manufacturer that begins to disseminate information in compliance with 

this part, but subsequently fails to comply with this part, shall 

immediately cease disseminating information under this part. A 

manufacturer that discontinues, terminates, or fails to conduct with due 

diligence clinical studies that it certified it would complete under 

Sec.  99.201(a)(4)(ii) shall be deemed not in compliance with this part. 

A manufacturer shall notify FDA immediately if it ceases dissemination 

under this paragraph.